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  • Title: Association of valproic acid and 2-propyl-4-pentenoic acid concentrations with adverse reaction in 254 Chinese patients with epilepsy.
    Author: Ma H, Zhu W, Wang C, Pan J, Yang X, Luo J, Wang P.
    Journal: Zhong Nan Da Xue Xue Bao Yi Xue Ban; 2019 Jul 28; 44(7):775-783. PubMed ID: 31413215.
    Abstract:
    To investigate the correlation of the concentrations of valproic acid (VPA) and 2-propyl-4-pentenoic acid (4-ene-VPA) with their adverse reactions, and to guide the clinical safety and rational use of VPA.
 Methods: We collected 254 epilepsy outpatients who took long-term use of sodium valproate oral solution single or combined with other antiepileptic drugs from Xiangya Hospital. The plasma concentrations of VPA and 4-ene-VPA in patients were determined by gas chromatography-mass spectrometry (GC-MS). The double variable correlation analysis was performed to analyze the effect of plasma 4-ene-VPA and VPA concentrations on adverse reactions.
 Results: The correlations between the PLT level and the dosage of VPA (P<0.01 and P<0.05, respectively), and the RBC level and the concentration of VPA (All P<0.01) were significant negatively. The concentrations of 4-ene-VPA, VPA, ALT, and AST in the polytherapy group were much higher than those in the monotherapy group (All P<0.05). In the monotherapy group, the ALT and AST levels in patients younger than or equal to 2 years old were significantly higher than those over 2 years old (P<0.001). In the polytherapy group, the levels of AST, WBC, and PLT in patients younger than or equal to 2 years old were higher than those over 2 years old (P<0.05). The levels of AST did not show positive correlation with the concentrations of 4-ene-VPA and VPA (r=0.031, r=0.035, all P>0.05), and the levels of ALT also did not show positive correlation with the concentrations of 4-ene-VPA and VPA (r=-0.064, r=-0.089, all P>0.05).
 Conclusion: VPA may affect blood routine indexes. Age and combination therapy with the non-enzyme-induced anti-epileptic drugs are risk factors for VPA-related liver dysfunctions and renal impairment. The determination of VPA and 4-ene VPA is not a suitable tool for early warning of the VPA-induced liver dysfunction. 目的：分析丙戊酸(valproic acid，VPA)及其毒性代谢物2-丙基-4-戊烯酸(2-propyl-4-pentenoic acid，4-ene-VPA)的血药浓度与二者所致不良反应的相关性，为临床安全合理使用VPA提供依据。方法：收集中南大学湘雅医院门诊确诊为癫痫，且长期服用丙戊酸钠口服溶液单药或者合并用药的254例患者，采用气相层析-质谱联用法测定血中VPA和4-ene-VPA浓度，采用双变量相关分析对血中VPA和4-ene-VPA浓度与所致不良反应的关系进行分析。结果：血小板(PLT)数量与VPA给药剂量呈显著负相关(P<0.01和P<0.05)，红细胞(RBC)数量与VPA浓度呈显著负相关(P<0.01)；合并用药组中4-ene-VPA，VPA，谷丙转氨酶(ALT)和谷草转氨酶(AST)均显著高于单药组(P<0.05)；在单药组中≤2岁患者组ALT和AST显著高于>2岁患者组(P<0.001)；在合并用药组中，≤2岁患者组AST，WBC和PLT水平同样显著高于>2岁患者组(P<0.05)。AST与4-ene-VPA和VPA浓度之间不相关(分别为r=0.031，r=0.035，P>0.05)，ALT水平与4-ene-VPA和VPA浓度之间亦不相关(分别为r=–0.064，r=–0.089，P>0.05)。结论：VPA可能影响血常规指标，年龄、合并其他非肝药酶诱导抗癫痫药是VPA相关肝肾功能异常的危险因素，血中VPA及4-ene-VPA浓度监测不适合预警丙戊酸所致的肝毒性。.
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